Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)
Condition(s) studied
Investigational drug(s) / intervention(s)
Ensifentrine: Delivered twice daily by oral inhalation via a standard jet nebulizer
Placebo: Placebo matched to ensifentrine delivered twice daily by oral inhalation via a standard jet nebulizer
Standard of Care (SOC): Background treatment of LAMA/LABA/ICS or LAMA/LABA (if ICS is not appropriate) administered per product approved label delivered by oral inhalation as part of standard of care
Study summary
The purpose of this study is to evaluate the efficacy and safety of ensifentrine (MK-5884) compared with placebo for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment. The study will also evaluate the efficacy of ensifentrine compared with placebo in improving lung function, improving health related quality of life, and preventing severe exacerbations.
Eligibility
Primary outcome measure(s)
- Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations — Up to 52 Weeks
The annualized rate of moderate or severe exacerbations over 52 weeks will be reported.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Family First Medical Research Center ( Site 4458) | Hialeah Gardens | Florida | Recruiting |
| Advanced Pulmonary Research Institute ( Site 4427) | Loxahatchee Groves | Florida | Recruiting |
| Velocity Clinical Research ( Site 4464) | Valparaiso | Indiana | Recruiting |
| CHEAR Center LLC ( Site 4407) | The Bronx | New York | Recruiting |
| Lowcountry Lung & Critical Care, PA ( Site 4413) | Charleston | South Carolina | Recruiting |
| M3 Wake Research, Inc. ( Site 4440) | Chattanooga | Tennessee | Recruiting |
| Victoria Clinical Research Group ( Site 4430) | Victoria | Texas | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07874815 on ClinicalTrials.gov ↗ ← All trials in the USA